By T. Singer (auth.), J. Venitz, W. Sittner (eds.)
Optimal dose individualization has turn into extra very important in bettering medical efficacy and security, given the variety in drug reaction, e.g., as a result of concurrent health problems or co-medications. for this reason, the position of optimum dose discovering in early scientific drug improvement with a view to maximize winning medical use is emphasised. the ongoing use of biomarkers – according to the (known) pharmacology of the drug and/or biology of the underlying illness – in addition to exposure–response overview all through all stages of drug improvement can quantitatively combine medical pharmacology wisdom, offer early facts of suggestion, and assist in rational dose choice and rational drug product labeling for scientific use.
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Extra info for Appropriate Dose Selection — How to Optimize Clinical Drug Development
Use of Biomarkers in Early Drug Development . . . . . . Case Example . . . . . . . . . . . . . . Ex Vivo and in Vivo Biomarkers of Synthetic Allosteric Modiﬁers Utility of Biomarkers for Exposure–Response and Proof of Concept for Efaproxiral . . . . . . . . 4 Conclusions . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . 49 49 50 51 53 53 56 58 58 58 61 62 Abstract. Biomarkers (BMs) are biological measures of PD drug effects or disease markers that may represent clinically signiﬁcant patient outcomes, either efﬁcacy or toxicity.
Revision 1, 23 June 2004, cited 6 April 2006 Microdosing in Exploratory Clinical Studies 27 FDA (1996) Guidance for Industry: Single Dose Acute Toxicity Testing for Pharmaceuticals. CDER, August 1996. htm FDA (2005) Exploratory IND studies (contains nonbinding recommendations draft – not for implementation) April 2005 Pharmacology/Toxicology. htm. Cited 6 April 2006 Food and Drug Administration (2006) FDA Critical Path Initiative – The critical path to new medical products. gov/oc/initiatives/criticalpath/.
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